Container closure for lyophilized products

ABSTRACT

The specific disclosure provides an integrally formed closure for a lyophilized product container having a neck, an upwardly facing opening in the neck and an external radial bead on the neck. The closure comprises a downwardly extending stopper portion having port means for venting the container during a lyophilization process, and means for seating the closure in a first position in the neck during the lyophilization process with the port means being positioned at least in part above the opening. The closure also includes a downwardly extending tear away skirt portion having means for engaging the bead when the closure is seated in a second position in the neck with the port means positioned below the opening to prevent venting of the container.

[ Sept. 10, 1974 1 CONTAINER CLOSURE FOR LYOPHILIZED PRODUCTS [75]Inventor: Ralph A. Bartell, Parsippany, NJ.

[73] Assignee: Warner-Lambert Company, Morris Plains, NJ.

[22] Filed: Nov. 20, 1972 [21] Appl. No.: 308,096

[52] US. Cl 215/256, 215/46 A, 215/56 [51] Int. Cl. B6Sd 41/46, B65d51/16 [58] Field of Search 215/41, 46 A, 56, 47

[56] References Cited UNITED STATES PATENTS 2,526,225 10/1950 Gronemeyer215/47 Primary Examiner-Donald F. Norton Attorney, Agent, or Firm-JamesF. Powers, Jr.; Albert H. Graddis [57] ABSTRACT The specific disclosureprovides an integrally formed closure for a lyophilized productcontainer having a neck, an upwardly facing opening in the neck and anexternal radial bead on the neck. The closure comprises a downwardlyextending stopper portion having port means for venting the containerduring a lyophilization process, and means for seating the closure in afirst position in the neck during the lyophilization process with theport means being positioned at least in part above the opening. Theclosure also includes a downwardly extending tear away skirt portionhaving means for engaging the bead when the closure is seated in asecond position in the neck with the port means positioned below theopening to prevent venting of the container.

6 Claims, 4 Drawing Figures CONTAINER CLOSURE FOR LYOPHILIZED PRODUCTS 7BACKGROUND OF THE INVENTION 1. Field of the Invention The presentinvention relates to closures for containers such as those used in thepharmaceutical industry. More particularly, the present inventionrelates to container closures for lyophilized products wherein theclosures have a tear-away portion to permit initial removal of theclosures from the containers.

2. Description of the Prior Art Lyophilization, gelsiccation or freezedrying are used to describe a technique which has been known for manyyears. The technique is a valuable processing scheme for apharmaceutical manufacturer, and has been used to dehydrate substancessuch as biologicals, serums, hormones, blood coagulation reagents andchemistry control reagents. The substances subjected to a lyophilizationprocess are typically those which are destroyed or impaired'at normaldrying temperatures. Such substances are usually unstable whenmaintained in solution for a long period of time, and are generallyrequired to be refrigerated to prevent spoilage.

A lyophilization process generally provides for freezing substances ator below 40 F., and thereafter subjecting the substances to low absolutepressures. For example, at absolute pressures lower than 3 mm. ofmercury, frozen water will pass from a sold to a gaseous state withoutbecoming liquid (sublime).

It is known to use a two-piece closure for sealing a container after theproducts therein have been lyophilized. This known two-piece closureconsists of a rubber stopper having a pair of vertical slots extendingupwardly from the bottom of the stopper portion, and a metallic tearoffcap. The rubber stopper is partially inserted in the neck of a containerwith the slots extending above the neck for venting the container duringthe lyophilization process. After the process has been completed, therubber stopper is fully inserted in the container such that the slotsare sealed from a surrounding environment. Thereafter, the container isremoved from the lyophilization apparatus and fed to an apparatus forsecuring the metallic cap about the upper end of the rubber stopper andthe neck of the container. U.S. Pat. No. 3,480,171 discloses a similartwo-piece container closure, but without the vertical slots in thestopper portion.

The two-piece closure of U.S. Pat. No. 3,480,171 requires a separateapparatus for installing the tear-off metallic cap on the container.Further, removal of such tear-off metallic caps presents a risk ofinjury to the user.

SUMMARY OF THE INVENTION It is an object of the present invention toprovide a one-piece closure for a lyophilized product container whereinthe closure functions for venting the container during lyophilization,and functions as a tamperproof closure after lyophilization.

Another object of the present invention is to provide a closure forlyophilized product containers which may be removed easily and quicklywithout risk of injury to a user.

Still another object of the invention is to provide a closure for alyophilized product container which is ccdownwardly from the top wall.The stopper portion comprises port means for venting the containerduring a lyophilization process, and means for seating the closure in afirst position in the neck during the lyophilization process with theport means being at least in part above the opening. The closure furthercomprises a tear-away skirt portion extending downwardly from the topwall, and including means for engaging the bead when the closure isseated in a second position in the neck with the port means positionedbelow the opening to prevent venting of the container.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a side elevation view of aclosure and container embodiment of the present invention with theclosure positioned for venting the container during a lyophilizationprocess;

FIG. 2 is a cross-sectional view taken along Line ,22 of FIG. 1, butshowing the closure fully seated in the neck of the container after thelyophilization process;

FIG. 3 is a bottom plan view of the closure shown in FIG. 1; and

FIG. 4 is a cross-section of a portion of the closure of FIG. 1.

DESCRIPTION OF SPECIFIC EMBODIMENTS With reference to the drawings,there is shown a container closure 10 associated with a containerembodied as a glass bottle 12. The bottle 12 has a reduced neck 39 andan external radial bead or flange 40 adjacent to an opening at the topof the neck 39. The bead 40 has an annular sharply angled shoulder 41spaced downwardly from the opening in the neck 39.

The closure 10 has a top wall 14, and a hollow cylindrical stopperportion 22 extending downwardly from the central region of the top wall14. The stopper portion 22 has an annular beveled section or seat 24,and a bottom section or end 26 of reduced outer diameter extendingdownwardly from the seat 24. Four vertical slots 27 30 extend verticallythrough the lower end 26 and the seat 24 and into the upper section ormain body of the stopper portion 22.

An outer wall 16 extends downwardly from the top wall 14 to complete atop wall portion of the closure 10. The outer wall 16 is concentricallyaligned with the stopper portion 22 and is spaced therefrom to form anannulus 15. A tear-away skirt portion 20 is concentrically aligned withthe outer wall 16 of the top wall portion, and is joined to the lowerend of the outer wall 16 by a thin horizontal annular section 18 (FIG.2). As shown in FIG. 2, the tear-away skirt portion extends.

downwardly about the bead 40, and has an internal circular rib 42 forabutting engagement with the shoulder 41 of the bead 40. The rib 42preferably has a sharply angled or square upper corner to provide atight-fitting interlock with the angular shoulder 41. The rib 42 isshown with a rounded or beveled bottom corner 44 for cooperation withthe outer surface of the head 40 to guide the closure 10 over the bead40 during assembly of the closure I to the bottle 12 as shown in FIG. 2.

A groove 30' extends vertically along the outer surface of the skirtportion 20, and another vertical groove 32 extends along the innersurface of the skirt portion 20 through the rib 42 to provide a thinfrangible or tearable section 31. A pull tab 51 is joined to the lowerend of the skirt portion 20 by a member 50. Intermediate portions of thepull tab 51 may also be joined to the lower end of the skirt portion 20by a plurality of readily frangible members 51.

The closure is integrally formed of flexible and resilient materialwhich, when stretched or otherwise deformed, tends to return to anoriginal shape so that the closure 10 can be made to engage the internaland ex temal portions of the bottle 12 in fluid tight contact. One suchsuitable material is polyethylene which, in the molded state, providesthe necessary degree of strength and firmness.

As shown in FIG. 1, the closure 10 is seated in a first position in theneck 39 of the bottle 12 with the annular beveled seat 24 in abuttingcontact with the inner surface of the neck 29 defining the neck openingIn this position, the slots 27 30 extend above the opening in the neck39 for venting the interior of the bottle 12 during a lyophilizationprocess on a liquid 13 in the bottle 12. After the lyophilizationprocess is completed, a movable member 1] is moved into abutting contactwith the outer surface of the top wall 14 and applies a force to the topwall 14 to seat the closure 10 in a second position shown in FIG. 2wherein the ports or vertical slots 27 30 are positioned below theopening in the neck 39, and the closure 10 provides a fluid seal for thelyophilized product 13 in the bottle 12.

As noted above, the beveled or rounded corner 44 at the lower end of theskirt portion guides the skirt portion 20 over the bead 40 while theclosure 10 is moved from the first position shown in FIG. 1 to thesecond position shown in FiG. 2. In the position shown in FIG. 2, theangular upper surface of the rib 42 is snap-locked into abuttingengagement under the angular shoulder 41 of the bead 40. When thuspositioned on the bottle 12, the closure 10 is effectively tamperproofbecause any attempt to move the angular rib 42 over the angular shoulder41 of the bead 40 will produce visible damage.

An outward force applied by a user to the pull tab 51 readily parts thefrangible elements 51' and removes the tear-away skirt portion 20 by atearing action upwardly along the vertical tearable section 31 andaround the annular thin section l8.

What is claimed is:

1. An integrally formed closure for a lyophilized product container;wherein said container comprises a neck, an upwardly facing circularopening in said neck and an external radial bead on said neck, saidopening having a predetermined diameter; said closure comprising:

a top wall portion,

a stopper portion extending downwardly from said top wall portion,

said stopper portion comprising an upper cylindrical section having anouter diameter greater than said predetermined diameter, a bottomcylindrical section having an outer diameter less than saidpredetermined diameter, an annular beveled section interconnecting saidupper and bottom sections, and port means for venting said containerduring a lyophilization process,

said beveled section providing means for seating said closure in a firstposition in said neck during the lyophilization process with said portmeans positioned at least in part above said opening, and

a tear-away skirt portion extending downwardly from said top wallportion, and including means for engaging said bead when said closure isseated in a second position in said neck with said port means positionedbelow said opening to prevent venting said container. 2. The closure ofclaim 1 wherein said stopper portion is hollow, and wherein said portmeans comprises a plurality of slots extending upwardly through saidbottom section, said beveled section and to a level above said beveledsection.

3. The closure of claim 1 wherein said skirt portion is joined to saidtop wall portion by a thin annular horizontal section; and wherein saidskirt portion further includes another thin section extending downwardlyfrom said horizontal section to the bottom edge of said skirt portion,and a pull tab adjacent to said downwardly extending section.

4. The closure of claim 3 wherein said bead engaging means comprises aninwardly projecting circular rib.

5. The closure of claim 4 wherein said top wall portion is in abuttingcontact with the uppermost surface of said neck when said closure is insaid second position.

6. The closure of claim 4 wherein the lower surface of said bead isangularly formed, and wherein the upper surface of said rib is angularlyformed for interlocking engagement with the lower surface of said beadwhen said closure is in said second position.

1. An integrally formed closure for a lyophilized product container;wherein said container comprises a neck, an upwardly facing circularopening in said neck and an external radial bead on said neck, saidopening having a predetermined diameter; said closure comprising: a topwall portion, a stopper portion extending downwardly from said top wallportion, said stopper portion comprising an upper cylindrical sectionhaving an outer diameter greater than said predetermined diameter, abottom cylindrical section having an outer diameter less than saidpredetermined diameter, an annular beveled section interconnecting saidupper and bottom sections, and port means for venting said containerduring a lyophilization process, said beveled section providing meansfor seating said closure in a first position in said neck during thelyophilization process with said port means positioned at least in partabove said opening, and a tear-away skirt portion extending downwardlyfrom said top wall portion, and including means for engaging said beadwhen said closure is seated in a second position in said neck with saidport means positioned below said opening to prevent venting saidcontainer.
 2. The closure of claim 1 wherein said stopper portion ishollow, and wherein said port means comprises a plurality of slotsextending upwardly through said bottom section, said beveled section andto a level above said beveLed section.
 3. The closure of claim 1 whereinsaid skirt portion is joined to said top wall portion by a thin annularhorizontal section; and wherein said skirt portion further includesanother thin section extending downwardly from said horizontal sectionto the bottom edge of said skirt portion, and a pull tab adjacent tosaid downwardly extending section.
 4. The closure of claim 3 whereinsaid bead engaging means comprises an inwardly projecting circular rib.5. The closure of claim 4 wherein said top wall portion is in abuttingcontact with the uppermost surface of said neck when said closure is insaid second position.
 6. The closure of claim 4 wherein the lowersurface of said bead is angularly formed, and wherein the upper surfaceof said rib is angularly formed for interlocking engagement with thelower surface of said bead when said closure is in said second position.